Published February 19 2026 this regulatory update reviews a trial testing cold spray and Buzy device to reduce pain and fear during penicillin injection.
The study covers injection events, aims to manage pain and anxiety, and compares three study arms: Cold Spray Intervention Group, Buzy Device Intervention Group, and a Control Group. Sponsor is Inonu University and the trial status is not yet recruiting. The ClinicalTrials.gov identifier is NCT07418021.
In this article we examine the data potential and regulatory implications of these interventions for device makers and health care providers. Below you will find the main sections that explain what changed, what is being tested, and what this could mean for policy and practice.
What is being studied?
The trial investigates whether topical cold spray or a Buzy device can mitigate pain and fear during penicillin injections. Participants are assigned to one of three arms: a cold spray group, a Buzy device group, or a standard care control group. The sponsor Inonu University is noted and the entry indicates not yet recruiting. The intervention aims to reduce pain scores and distress and to improve patient experience in the injection setting. Registry data is available on ClinicalTrials.gov under NCT07418021. This demonstrates ongoing interest in non pharmacologic methods to improve the injection experience and aligns with patient experience outcomes in regulatory submissions.
Which devices are tested and how are they used?
The Cold Spray Intervention Group applies a rapid cooling spray to the skin before the needle insertion. The Buzy Device Intervention Group uses a handheld device that delivers vibrations at the injection site to alter pain perception. The Control Group uses standard care without active devices. The sponsor expects to collect pain and fear outcomes and to monitor for adverse events. The trial status remains not yet recruiting at this time, a factor regulators will monitor for updates and potential labeling or guidance changes. The ClinicalTrials.gov entry provides the official record for investigators and regulatory teams to track progress.
What are the regulatory implications for pain management devices in injections?
Regulators will assess whether cold spray and the Buzy device meet the intended use and performance expectations in an injection setting. MDR style practice requires clear intended purpose, performance characteristics, and safety information. These devices are evaluated as non pharmacologic aids to reduce pain and fear. Sponsors may need to document device performance, clinician training, and risk controls. If trial results show meaningful benefit and acceptable safety, labeling statements or supportive evidence could be considered in regulatory submissions. It remains essential to distinguish device claims from observed clinical outcomes in routine care. The registry note that the trial is not yet recruiting, which can influence planning and timelines for data collection. The source link to ClinicalTrials.gov remains the primary reference for updates.
FAQ
- 1. What is the purpose of this trial? The trial aims to compare a cold spray method and a Buzy device against standard care to reduce pain and fear during penicillin injections.
- 2. Who funds the study? The sponsor is Inonu University, a public higher education institution listed in the registry.
- 3. What outcomes are measured? Pain intensity, fear responses, and adverse event reporting are among the outcomes tracked.
- 4. When will results be available? The registry notes that the trial status is not yet recruiting; updates will appear on ClinicalTrials.gov as enrollment proceeds.
- 5. Where can official details be found? Official details are posted on ClinicalTrials.gov under identifier NCT07418021.
Conclusion
The trial highlights a growing interest in device based pain and fear management for injections. If results show benefit and an acceptable safety profile, manufacturers may pursue expanded labeling or clinician guidance for these methods. Health care teams should monitor the registry for changes in recruitment status and any regulatory updates related to device claims and usage guidelines. Clinicians and regulators alike should evaluate data within the broader framework of patient experience and safety and consider how such tools may align with existing pain management standards.
Disclaimer
This article is for professionals and is not legal advice. It summarizes a clinical trial entry and regulatory considerations in plain language. It does not substitute for official guidance, nor does it change regulatory requirements.
Announcement line
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07418021?term=medical+device